Dexcom Inc. received U.S. FDA clearance for its Smart Basal CGM-integrated basal insulin dosing optimizer. Designed for adults with type 2 diabetes using glargine U-100 long-acting insulin therapy, Smart Basal uses data from Dexcom’s G7 15 Day sensor with doses logged by the user to personalize recommendations and adjust long-acting insulin doses, with direction from the patient’s health care provider.

The recent strategic partnership Siemens Healthineers AG recently entered into with Boston Scientific Corp. to develop and commercialize an Acunav 4D intracardiac echocardiography catheter could drive “significant growth” for the company, Jochen Schmitz, CFO, at Siemens, told delegates at the Jefferies Global Healthcare Conference, in London.

U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.

A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.

Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.

Aesculap Implant Systems LLC has seen its share of bad news recently, but the company seems to have cleared the legal deck with an agreement to pay $38.5 million per a Nov. 17 announcement by the U.S. attorney’s office for the district of Eastern Pennsylvania.

Over a span of five-and-a-half months this year, 3.5% of the more than 11,000 clinical trials funded by the U.S. NIH had their grants terminated, according to an article published in the Nov. 17 JAMA Internal Medicine. That’s 383 trials that lost funding.

The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.

Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand.

Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.