Companies

Relievant’s Intracept intraosseous nerve ablation system is the only FDA-cleared neuromodulation device indicated to treat vertebrogenic pain. Boston Scientific will pay $850m for Relievant, plus undisclosed milestone payments over the next three years.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

Parse Biosciences’ motion to dismiss a patent infringement case has been rejected by a US District Court.

The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.

A new decision from the PTAB upholds prior rulings rejecting four of Masimo’s appeals and reverses a decision on one.

As part of its ongoing effort to modernize its premarket notification 510(k) program, the US FDA has issued three draft guidance documents it says will improve the safety of critical medical devices and strengthen the submission process.

The genome-sequencing giant has named Jacob Thaysen, who brings extensive experience from Agilent, as its new leader.

Abbott and Bigfoot Biomedical have worked as partners for more than half a decade but will now continue as one. Analysts are questioning whether the merger will simply be a tuck-in for Abbott, or enable it to release an insulin pump of their own.

The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.

Medtronic has identified additional HeartWare Ventricular Assist Device pumps that the company says have a higher risk of failure than average for the devices.

The ActiGraft PRO treatment for diabetic ulcers recently procured Medicare coverage nationwide, despite anti-abuse policies that have made reimbursement for new wound care products rare. Company general manager Robert Mueller talked about the process.

After a summer of speculation about who will close the deal with Abcam, tech leader Danaher came out ahead and will acquire Abcam for $24 a share.

Medtech Insight followed up with Invitae’s Deven McGraw about further possible confusion that could be caused by the Federal Trade Commission’s proposed amendments to the Health Breach Notification Requirements (HBNR).

After an inspection of its Boston facility, the US FDA issued a warning letter to Integra LifeSciences' subsidiary TEI Biosciences for distributing collagen-based medical devices that failed bacterial endotoxin tests and did not conform to good manufacturing practices.

Philips recalled thousands of Trilogy Evo ventilators in March. The US FDA has designated the recall class I, its most serious type. 

The US Food and Drug Administration is warning consumers not to use more than a dozen diagnostics from Universal Meditech, including pregnancy tests and those to detect urinary tract infections.