MedTech Europe says MDR, IVDR framework needs ‘structural reform’

Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.

By Susan Kelly • Sept. 18, 2023

FDA finalizes breakthrough device changes to target health inequities

The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.

By Nick Paul Taylor • Sept. 18, 2023

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Beacon Biosignals receives FDA clearance for sleep tracking headband

The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.

By Nick Paul Taylor • Sept. 18, 2023

Bigfoot CEO talks Abbott acquisition, future of diabetes tech

Jeffrey Brewer hopes to see more integrated solutions for people with diabetes, starting with the company’s partnership with Abbott.

By Elise Reuter • Sept. 15, 2023

Hospital, lab equipment makers brace for China demand slowdown

Chinese purchases represent 10% to 20% of revenues on average for leading companies in the life science tools sector, according to Jefferies research.

By Susan Kelly • Sept. 15, 2023

J&J to phase out Janssen name in corporate rebrand

Janssen will be recast as Johnson & Johnson Innovative Medicine, while the company’s medical device business will remain Johnson & Johnson MedTech.

By Ned Pagliarulo • Sept. 15, 2023

GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.

By Nick Paul Taylor • Sept. 15, 2023

Insulin pump-makers grapple with questions about GLP-1s

The new class of weight loss drugs has caused a stock selloff, but is unlikely to “meaningfully change the long-term outlook for diabetes,” analysts wrote.

By Elise Reuter • Sept. 14, 2023

FTC closes probe of Resonetics’ $900M medical nitinol purchase

The acquisition would give Resonetics a leading supplier of the alloy for the medical device industry.

By Elise Reuter • Sept. 14, 2023

Abbott’s neurostimulator recall, with 73 injuries reported, deemed Class I by FDA

The company contacted customers in July after receiving complaints from patients who were unable to exit the devices’ MRI mode.

By Nick Paul Taylor • Sept. 14, 2023

FDA finalizes biocompatibility guidance for devices that touch the skin

The agency chose not to make some major requested revisions, such as including metals in the scope of the guidance.

By Nick Paul Taylor • Sept. 14, 2023

Akili cuts 40% of workforce, plans shift to non-prescription model

The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

By Elise Reuter • Sept. 13, 2023

Orthofix fires CEO, CFO after investigation finds misconduct

The executives engaged in “repeated inappropriate and offensive conduct” inconsistent with the company’s values, Orthofix said.

By Susan Kelly • Sept. 13, 2023

FDA finalizes combination product guidance 7 years after sharing draft

AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”

By Nick Paul Taylor • Sept. 13, 2023

TB deaths prompt FDA warning on reducing transmission risk

The agency outlined risk mitigation strategies for cell and tissue products after two recipients of bone matrix products died.

By Nick Paul Taylor • Sept. 13, 2023

CMS digs deeper into impact of proposed breakthrough device pathway in JAMA paper

The article discusses what the TCET pathway will mean for products at different stages of the life cycle.

By Nick Paul Taylor • Sept. 12, 2023

Bausch + Lomb seeks funding for $1.75B eye drop acquisition from Novartis

Fitch Ratings called the deal to buy the Xiidra treatment “strategically sound” even as the company’s plan to fund it would increase its leverage.

By Nick Paul Taylor • Sept. 12, 2023

Centinel Spine to sell fusion business, focus on disc replacement

Switzerland’s Silony Medical, which is buying the technology, sees itself as a challenger to “big medtech” in spinal fusion.

By Susan Kelly • Sept. 11, 2023

Sterigenics’ $408M ethylene oxide settlement removes ‘most problematic’ lawsuits: analysts

Remaining lawsuits pose less of a threat to the medical device sterilizer, and tighter emissions standards seem achievable, KeyBanc analysts wrote. 

By Nick Paul Taylor • Sept. 8, 2023

PFA procedures expected to rise after Boston Scientific study results

Analysts estimate the technology could be used in up to half of all cardiac ablation cases in a few years. 

By Elise Reuter • Sept. 8, 2023

Intuitive’s Tony Jarc on how AI is improving robotic surgery

The company aims to help surgeons achieve better results for patients and hospitals.

By Susan Kelly • Sept. 8, 2023

Bayer faces Essure lawsuit after UK court clears 200 women to claim for damages

Bayer has vowed to defend itself “vigorously” against claims that could cost the company more than $12 million in damages.

By Nick Paul Taylor • Sept. 8, 2023

Zimmer Biomet promotes 3 executives

The appointments come less than a month after the company elevated Ivan Tornos to the CEO position.

By Susan Kelly • Sept. 7, 2023

Philips reaches settlement in US respiratory device litigation

The company will pay more than $479 million to resolve all economic loss claims. The settlement does not include injury or medical monitoring claims. 

By Elise Reuter • Sept. 7, 2023

FDA proposes 3 guidances to improve 510(k) clearance process

The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.

By Nick Paul Taylor • Sept. 7, 2023