Boston Scientific to buy back pain treatment company Relievant for $850M

The company, which makes a treatment for chronic back pain, is expected to bring in more than $70 million in sales this year.

J&J starts trial of pulsed field ablation catheter with mapping feedback

Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data.

Gates Foundation grants GE HealthCare $44M for AI ultrasound tech

The money will go to subsidiary Caption Health to make AI tools to help with maternal care and pediatric lung health.

FDA releases draft guidance for studying weight loss devices

The documents arrive amid questions about whether new medicines will cut demand for weight loss procedures.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

FDA finalizes combination product guidance 7 years after sharing draft

AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”

Study suggests AI could provide second reading of mammograms

In a separate commentary, researchers described the study as launching “the arrival of prospective trials of AI in the breast screening setting.”

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.

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.

FDA approves updated COVID boosters from Pfizer, Moderna

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

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. 

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.