The medtech regulatory authorities in Switzerland have pledged to follow the EU’s lead in granting extended transition periods for legacy devices under the MDR.

The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.

The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.

The FDA’s new framework for the use of digital health technologies will engage stakeholders to provide more guidelines for the industry.

The UK continues to work on its new medtech regulatory system and market access processes for innovations, but all the planning and preparations will count for little if not accompanied by sound execution, warns Lincoln Tsang of law firm Ropes & Gray.

The US FDA’s guidance document on animal testing for medical devices clarifies the scope of a document issued in 2016.

The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.

The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.

The US FDA’s guidance document on animal testing for medical devices clarifies the scope of a document issued in 2016.

Robotic surgery pioneer and co-founder of Intuitive Surgical Frederic Moll joined Daniel Hawkins, Intuitive’s first non-technical hire, for a discussion on the evolution of surgical robotics and outlook for the future.

In this special podcast from Medtech Insight, editor Reed Miller talked to Andrie Leday, the US vice president for ambulatory surgery centers (ASCs) at Johnson & Johnson/DePuy Synthes. Leday's group is dedicated to creating a new "ecosystem" around DePuy Synthes' broad range of orthopedic implants and tools to meet the demand of an aging population.

Leaders of burgeoning ophthalmology companies pitched innovations for treating glaucoma, macular degeneration and corneal blindness to potential investors and partners at the LSI Emerging Medtech Summit in Dana Point, CA. Here’s what Medtech Insight heard and learned in on-site interviews with chief executives.

The US Food and Drug Administration recently issued updates regarding improvements to its online submissions portal, enhancements to its electronic medical device reporting system, pediatric X-ray guidance, expanded indications for a popular breathing device, and mammogram guidelines; and more news we’re watching.

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition focuses on clinical trial presentations from three recent conferences: American College of Cardiology in New Orleans, Cardiovascular Research Technologies in Washington, DC, and Technology and Heart Failure Therapeutics in Boston.

Despite earlier efforts to restructure, the company is still struggling to meet its revenue targets, and issued a statement suggesting that further measures, including liquidation, may be necessary.

In this special podcast from Medtech Insight, editor Reed Miller talked to Andrie Leday, the US vice president for ambulatory surgery centers (ASCs) at Johnson & Johnson/DePuy Synthes. Leday's group is dedicated to creating a new "ecosystem" around DePuy Synthes' broad range of orthopedic implants and tools to meet the demand of an aging population.

Results of the PULSED AF trial confirm that Medtronic’s PulseSelect pulsed field ablation is safe and effective for atrial fibrillation ablation. The company will likely incorporate PulseSelect into its Affera cardiac mapping and ablation system, which will soon be available in Europe.

Medtech Insight spoke with Stephen Hahn, ex-FDA commissioner and CEO of Harbinger Health, who attended SXSW, about the firm’s blood-based cancer test in development.

AdvaMed’s Medical Innovation Agenda for the 118^th Congress emphasizes increased access to medical devices, from reimbursement for breakthrough devices to boosting America’s start-ups to closing the care disparities for underserved communities.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights how Alife Health is using its AI-based platform for IVF to increase chances for successful pregnancies while Barnaby Pickering discusses how AI Medical Technology is using AI to detect melanoma. Reed Miller talks about weight-loss device maker Allurion Technologies’ signed SPAC deal.

Abbott announced today it plans to integrate its FDA-cleared modified CGMs with insulin pump makers, including Tandem and Insulet, likely later this year.