Boston Scientific Corp. agreed to acquire the Baylis Medical Company Inc.’s cardiology business, Baylis Medical Co., for an upfront payment of $1.75 billion, subject to closing adjustments. The transaction is expected to close in the first quarter of 2022. Baylis Medical Technologies, which focuses on radiology and neurosurgery, is not part of the deal and will remain a separate entity.
Innerscope Hearing Technologies Inc. acquired the assets and operations of Ihear Medical Inc. for an undisclosed amount. The deal significantly boosts Innerscope’s position in the emerging market of direct-to-consumer and over-the-counter hearing products, an important development in the run-up to the FDA’s expected release next month of new regulations for hearing aids that can be sold in stores without a prescription.
Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.
A series A fundraising round lifted the mood at Genetikaplus Ltd. (Genetika+), raking in $10 million, a healthy 33% more than the initial target of $7.5 million. Proceeds from the round will go to fund trials of the Jerusalem-based company’s “brain-in-a-dish” technology for evaluating the best antidepressant for each patient. Greybird Ventures led the round, with participation by Meron Capital, Jumpspeed Ventures and Sapir Venture Partners.
Medtronic plc strengthened its suite of products for minimally invasive spine surgery with several new additions. The portfolio provides an integrated solution that includes implants, navigation, robotics, and artificial intelligence to streamline transforaminal lumbar interbody fusion (TLIF), customize treatment for patients and improve outcomes.
With fresh funds and a pivotal trial underway, Sommetrics Inc. may be about to shed its sleeper status. Executives at the Vista, Calif.-based company hope to provide a quiet, effective solution to obstructive sleep apnea (OSA) that’s less obtrusive and better tolerated than the continuous positive airway pressure (CPAP) machines that currently dominate the market.
Nonagen Bioscience Corp. received FDA breakthrough device designation for its liquid biopsy assay designed to predict response to treatment for bladder cancer. The test, Oncuria, measures 10 protein biomarkers in a urine sample and uses an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or should proceed to another treatment option.
Ernst and Young’s (EY) annual Pulse of the Industry report released today provided proof of med tech’s strong rebound from the disruption of the pandemic. Research and development investment soared, deal activity hit new highs, venture capital poured $9.1 billion into the sector, IPOs doubled, and more than 9 out of 10 of commercial leaders reported increased revenues.
Reports of increased alcohol use began early in the pandemic and, with many counseling services and physicians’ offices closed or more difficult to access, therapists worried that an increasing number of patients with substance use disorders would be unable to find effective treatment. In that gloomy setting, San Francisco-based Woebot Labs Inc. reported cheering news in the October issue of Drug and Alcohol Dependence.
Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan.
