STAT

FEBRUARY 1, 2024

Nevertheless, the concept of software-based tools designed to manage or treat medical conditions has received enormous attention in the U.S. South Korea is the only country to officially recognize digital therapeutics as a category. as proponents tout their potential to both widen access to care and improve patient outcomes. billion in 2021.

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STAT

JANUARY 30, 2024

The ubiquity of AI tools like ChatGPT could be a boon to hospitals eager for diagnostic aids or administrative assistants that can flag crucial medical details and ease the burden of repetitive tasks. But security experts say they can just as easily be harnessed by malicious hackers to exploit an industry known for outdated cyber protections.

Hospitals 293

Hospitals 293

STAT

DECEMBER 21, 2023

WASHINGTON — Sometime next year drug and medical device companies will have to tell the Food and Drug Administration how they plan to include people of color in clinical trials. Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials.

Drug Development 293

Drug Development 293

STAT

DECEMBER 7, 2023

Researchers at Duke University and Harvard Medical School have successfully demonstrated a proof of concept in new research published Thursday in Science using a 3D printer that uses ultrasound to print biomaterials inside an organ. Imagine getting surgery without ever being cut open. Read the rest…

Medical Schools 346

Medical Schools 346

STAT

NOVEMBER 21, 2023

If Paul Grand weren’t the CEO of MedTech Innovator, the largest medical device accelerator in the world, he might have been a keychain salesman. He started it to empower entrepreneurs discouraged by a funding dry spell precipitated by the 2009 financial crisis, and to fill the void of a medical device-specific accelerator.

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LifeProNow

JANUARY 19, 2024

Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. EtO is the most commonly used sterilization method for medical devices in the U.S.,

Labelling 130

Labelling 130

STAT

OCTOBER 24, 2023

government issued a proposal to gather information and opinions about payments that drug and device makers give to the medical community. which emerged from scandals and probes into undue industry influence over physicians and researchers. Earlier this month, the U.K. This was a really big thing in the U.K.

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STAT

FEBRUARY 23, 2023

In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move. Continue to STAT+ to read the full story…

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Express Pharma

MARCH 4, 2024

Dr Mansukh Mandaviya, Union Minister for Chemicals & Fertilizers and Health & Family Welfare virtually inaugurated 27 greenfield bulk drug park projects and 13 greenfield manufacturing plants for medical devices recently. It was also informed that when the PLI scheme came in, India imported 90% of medical devices.

Compounding 105

Compounding 105

FDA Law Blog: Biosimilars

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.

Documentation 105

Documentation 105

European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024.

Communication 81

Communication 81

Express Pharma

NOVEMBER 13, 2023

In the ever-evolving landscape of medical device assembly, innovation knows no boundaries. Leaders in medical device assembly are pioneering solutions with unprecedented capabilities to produce multiple product types, facilitating small-batch flexibility without compromising on productivity.

Packaging 108

Packaging Communication 108

STAT

SEPTEMBER 28, 2022

The Food and Drug Administration on Tuesday published a list of artificial intelligence tools that should be regulated as medical devices, in some cases appearing to expand its oversight of previously unregulated software products.

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STAT

JUNE 19, 2023

From people misunderstood by the medical system to those underwhelmed by the often perfunctory annual wellness check , increasingly savvy health consumers are self-assembling a personalized patchwork of products and services from the wellness industry.

Communication 245

Communication Immunity Immunization 245

STAT

OCTOBER 31, 2022

A slightly larger share of nurse practitioners, physician assistants, and other advanced practice clinicians accept payments from drug and device makers compared with physicians, a first-of-its-kind study found. Of all the advanced practice clinicians working in the U.S. Continue to STAT+ to read the full story…

Hospitals 180

Hospitals 180

PharmaTech

MAY 13, 2024

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges.

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pharmaphorum

DECEMBER 27, 2023

In this second of our festive podcast series, the pharmaphorum podcast welcomed Brandon Medical CEO Keith Jackson and the Association of British HealthTech Industries (or ABHI) director of communications, Jonathan Evans, to discuss UK medical device exports, including a particular recent strategic APAC partnership and the general and ongoing representation (..)

Communication 69

Communication 69

STAT

JULY 19, 2023

The rules would apply broadly across the economy, but they have strong implications for the health care industry, where sizable deals among hospitals, physician practices, private equity firms, health insurers, pharmacy benefit managers, pharmaceutical companies, medical device firms, and numerous other entities occur almost weekly.

Hospitals 146

Hospitals Pharmaceutical Companies Pharmaceutical Companies 146

Express Pharma

AUGUST 4, 2023

An inclusive process will help shape an appropriate Regulatory Policy that needs to impact the Medical Devices sector positively,” said Rajiv Nath, Forum Coordinator, AiMeD, and one of the signatories in the letter dated August 2, 2023, while appreciating the tremendous efforts being made to regulate the drugs and cosmetics sector. “An

Hospitals 85

Hospitals 85

FDA Law Blog: Biosimilars

MARCH 11, 2024

Lenz, Principal Medical Device Regulation Expert & Allyson B. Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions.

Communication 64

Communication 64

pharmaphorum

FEBRUARY 8, 2024

As the only industry-led forum for experts developing medical grade neurostimulation devices, the Bioelectric Medicine Development Summit (Boston | June 4-6) is dedicated to bringing bioelectric medicine experts together.

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FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

FDA announced that FDA, Health Canada, and MHRA are jointly publishing guiding principles for PCCPs for AI/ML devices to help stakeholders when developing solutions for these countries. Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device.

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Labelling Communication 115

pharmaphorum

JUNE 10, 2022

A lot of innovators are in the same boat as, despite laudable efforts by the agency, there’s still a lot of misinformation and a lack of clarity around how digital health devices, especially software as a medical device, are regulated. Drugs and devices are two completely different animals.

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Documentation 133

LifeProNow

MARCH 10, 2023

This is work that will have an immediate impact on food, tobacco and medical product safety in this country while also preparing the agency to address rapid innovation across the food and medical products fields. million increase toward improving the medical device supply chain and shortage programs. Califf, M.D.

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Labelling Packaging Controlled Substances 130

pharmaphorum

SEPTEMBER 29, 2022

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device. not a medical device, ii.

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Documentation 96

Pharma Marketing Network

APRIL 1, 2023

Pharma-Mkting.com is a leading resource for professionals in the pharmaceutical and medical device industries. With a focus on marketing and digital health, Pharma-Mkting.com provides a wealth of information, resources, and insights to help these industries succeed in an increasingly competitive market.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. (HP&M), is pleased to announce that Director Anne Walsh will be speaking at the DIA Advertising and Promotion Regulatory Affairs Conference.

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Express Pharma

SEPTEMBER 26, 2023

Dr Mandaviya said, “India can only achieve self-reliance in pharmaceuticals and medical devices by strengthening its research and development infrastructure that would drive the expansion of access to life-saving medicines and drugs and help India become a global pharma and medical exports hub.

Biosimilars 99

Biosimilars 99

FDA Law Blog: Biosimilars

JANUARY 28, 2024

FDA points to a nearly 50-year-old statute, the Medical Device Amendments (MDA), as the source of its supposed authority to regulate LDTs as medical devices—authority which it apparently chose to not enforce until now. Instead its text and structure affirmatively undermine the Proposed Rule’s core claims.

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European Pharmaceutical Review

MARCH 5, 2024

Artificial intelligence (AI) plays an increasingly important role in the laboratory world, especially in medical diagnostics. Analytics ensures product quality in the pharmaceutical industry The quality and performance of analytics play a crucial role in innovative therapies and the development of new drugs.

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Labelling 86

Pharma Mirror

SEPTEMBER 4, 2020

The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry.

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STAT

AUGUST 17, 2023

The health care industry didn’t just provide a safe haven for jittery stock investors in 2022, a year defined by inflation and higher interest rates. “This is the bitter fruit that we reap from telling the health care industry to act more like a business.” But health care still represents more than 18% of the U.S.

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Insurance Coverage and Processing Nursing Homes Prescription Filling Hospitals 246

Definitive Healthcare

AUGUST 8, 2022

Resource Type Whitepapers & Research Marketo form number 1747 Case Study Buyer's Guide Whitepaper Transforming a sales team with data-driven market intelligence from Definitive … Healthcare data & analytics buying guide for medical device firms Shifting point of care to ambulatory surgery centers Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHo

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FDA Law Blog: Biosimilars

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. By Adrienne R. The Draft Guidance provides specific examples illustrating the application of each scenario.

Medical Records 64

Medical Records 64

FDA Law Blog: Biosimilars

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

Communication 64

Communication 64

pharmaphorum

OCTOBER 12, 2022

Sustainability for Injectable Delivery Devices. Connected Drug Delivery Devices. This event will not only bring you key insights you need to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. Primary Packaging Development.

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Packaging 52

FDA Law Blog: Biosimilars

MARCH 19, 2024

is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers.

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