Scrip Approvals

Precise Bio Achieves Historic First 3D-Bioprinted Corneal Implant In Human, Part Of Early Trial

Marion Webb — Wed, 26 Nov 2025 23:35:32 +0000

Israel-based Precise Bio and Rambam Medical Center achieved a historic milestone by surgically placing the first ever 3D-bioprinted corneal implant into a patient who is legally blind in one eye. The

Tariffs In Focus: Projections From 4 Medtech Giants (Q1 Vs Q2)

Marion Webb|Shubham Singh|Nancy Pham — Fri, 29 Aug 2025 17:20:27 +0000

Roche Diagnostics: Navigating Trade & Manufacturing Challenges Q1 (April 24) Q2 (July 24) Intuitive Surgical: Managing Tariff Pressures Across Global Supply Chains Q1 (April 22) Jamie Samath, Intu

Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

Amanda Maxwell — Wed, 20 Aug 2025 09:30:58 +0000

The regulation of products on the borderline between drugs and devices, or of products combining aspects of drugs and devices, has long been troublesome, lengthy and costly. If not exclusively, this i

Injuries And Deaths Linked To Baxter Infusion Pump

Brian Bossetta — Wed, 23 Jul 2025 20:27:06 +0000

The Food and Drug Administration continues to use its enhanced communications pilot to provide advance warnings of potentially dangerous device safety issues, this time alerting the public about Baxte

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

Vibha Sharma — Thu, 03 Jul 2025 16:56:18 +0000

Several EU member states are actively participating in a new pilot program aimed at testing the feasibility of an innovative, coordinated pathway for evaluating applications for studies investigating

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

Elizabeth Orr — Tue, 01 Jul 2025 20:35:36 +0000

Unique device identifiers (UDIs) have been mandatory for most medical devices sold in the US for years now, but the picture for combination products has been murkier – especially when the UDI must com

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

Vibha Sharma — Mon, 30 Jun 2025 21:39:00 +0000

EU regulators are urging sponsors to keep an “open mind” when it comes to participating in their new pilot project on the coordinated assessment of applications for studies that investigate a drug pro

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

Brian Bossetta — Fri, 27 Jun 2025 18:53:35 +0000

The Food and Drug Administration is recommending certain Bravo CF capsule delivery devices be taken off the market after reports of 33 serious injuries from the product. The agency says there have bee

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

Vibha Sharma — Wed, 18 Jun 2025 20:01:34 +0000

Sponsors planning to run multinational combined studies in the EU that involve both the clinical trials of medicines and the performance studies of in vitro diagnostics are being invited to partic

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

Marion Webb — Wed, 07 May 2025 17:53:02 +0000

According to Galen Growth’s report digital health funding report titled “ Consumer HealthTech: A Paradigm Shift in Healthcare, ” investor confidence in digital health start-ups offering consumers to

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

Brian Bossetta — Tue, 25 Mar 2025 17:21:20 +0000

A Rhode Island patient advocacy group for chronic pain sufferers has petitioned the US Food and Drug Administration to classify and regulate a proprietary risk-scoring algorithm from Boston-based Ba

Recall Alerts For Boston Scientific, Philips, J&J, And More

Elizabeth Orr — Thu, 06 Mar 2025 19:57:30 +0000

Almost 900 serious injuries and deaths have been connected to seven device safety events recently announced by the US Food and Drug Administration. The bulk of the incidents are tied to Boston Scient

EU Pilots Streamlined Approach To Multinational Combination Product Trials

Vibha Sharma — Tue, 24 Dec 2024 20:24:26 +0000

EU member states have endorsed plans for several new projects to address the existing bottlenecks faced by sponsors running combined studies involving medicines, IVDs and/or medical devices. The pro

News We’re Watching: AMP Sues FDA To Block Lab-Developed Test Rule; FDA Guidances; ICU Medical Infusion Pump Correction

Brian Bossetta|Marion Webb|Elizabeth Orr|Natasha Barrow — Fri, 23 Aug 2024 22:54:11 +0000

FDA Faces Second Lawsuit On LDT Rule The Association for Molecular Pathology (AMP) has filed a lawsuit to block the US Food and Drug Administration from implementing a policy change that would apply a

FDA Drops Draft Guidance on Predetermined Change Control Plans for Medical Devices

Brian Bossetta — Wed, 21 Aug 2024 21:12:44 +0000

Sponsors may want to use predetermined change control plans (PCCPs) to describe planned modifications to medical devices, such as changes to sterilization or packaging, new raw device materials, or ce

Q&A Guidance Doc Dives Into Combination Product User Fees

Elizabeth Orr — Thu, 18 Jul 2024 22:22:44 +0000

Newly finalized guidance from the US Food and Drug Administration lays out how the agency assesses user fees for combination products, as well as how sponsors can qualify for waivers and other program

Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents

Brian Bossetta — Wed, 10 Jul 2024 20:36:22 +0000

The Federal Trade Commission has challenged more than a hundred medical device patents listed in the Food and Drug Administration’s Orange Book, claiming the improper listings stifle competition and f

FDA Offers Draft Guidance For Developers Of Drug Delivery Devices

Brian Bossetta — Tue, 02 Jul 2024 20:09:04 +0000

The Food and Drug Administration’s draft guidance — “ Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products ” — seeks to help developers of devices that deliver

ADDF Leaders Discuss Future Strategies In Alzheimer’s Research And Crucial Role Of Diagnostic Markers

Marion Webb — Thu, 13 Jun 2024 02:49:11 +0000

Over the last three years, researchers have made significant progress in defining key drivers of Alzheimer’s disease, which affects more than 50 million people worldwide. Tests such as a PET scan, MRI

EMA Answers More Questions For Manufacturers of Drug-Device Combos

Neena Brizmohun — Thu, 23 May 2024 20:46:00 +0000

Companies marketing integral drug-device combination products who want to make changes to the medicinal component might need to obtain a new/updated opinion from a notified body (NB) about the product