The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.
More bad news on the recall front for Royal Philips NV, as the U.S. FDA this week categorized the company’s voluntary recall of its Panorama 1.0T HFO open magnetic resonance (MR) system as a class I action. Class I recalls indicate the “use of the devices may cause serious injuries or death,” the FDA noted.
Glaukos Corp. brought home a nice year-end gift for investors with a broad U.S. FDA approval for the Idose TR. Indicated for use in patients with primary open-angle glaucoma or ocular hypertension across the full range of disease severity, the device/drug combo provides continuous release of a prostaglandin analog that reduces intraocular pressure via a titanium device implanted through a corneal incision for up to three years.
Henry Schein Inc., long known primarily as a dental equipment distributor, added two deals to its 2023 roster that will expand its presence in the orthopedics market. The company agreed to acquire a majority interest in Trimed Inc., which focuses on solutions for treatment of the upper and lower extremities and entered into a strategic relationship with Extremity Medical LLC.
The holidays are looking brighter for Masimo Corp. with two bits of good cheer this week for the company. Apple Inc. confirmed to BioWorld that it will preemptively pull two smartwatches from its website and retailers in response to a Masimo infringement case that persuaded the International Trade Commission to block their import.
Biotelemetry Inc. and its subsidiary, Lifewatch Services Inc., agreed to pay $14.7 million to settle a whistleblower case alleging overbilling for remote cardiac monitoring. The qui tam case contended that the company’s online portal for its ACT-3L/MCT-3L device and its staff consistently and intentionally forced physicians’ staff to select or themselves selected the most expensive application for the device, despite intent and even written instructions to choose a less expensive service.
Zimvie Inc. will sell its spine business to private equity investor H.I.G. Capital for $375 million, a move that should clean up its balance sheet and allow it to focus on the more profitable dental business. The deal is structured as $315 million in cash plus a promissory note for $60 million with an interest rate of 10%, compounded semi-annually.
After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal.
MLA Diagnostics BV secured a strategic seven-figure investment in its recent investment round to support external validation of the company’s melanoma prognosis test. Co-founders NLC Health Ventures and Brightlands Life Sciences Ventures participated in the round along with LIOF, the regional development organization for the Limburg province of the Netherlands.
