Zoll Medical Corp.’s plans to wake up the sleep apnea market segment advanced with the acquisition of Itamar Medical Ltd. for $538 million in cash. Itamar focuses on the diagnosis and treatment of sleep apnea, a common and complicating comorbidity of the cardiovascular patients served by Zoll. The deal continues Zoll’s acquisitive trend, following the purchase of Minnetonka, Minn.-based Respicardia Inc., another sleep apnea-focused company, in April and Therox Inc., of Irvine, Calif., in 2019. Zoll has operated as an Asahi Kasei Corp. subsidiary since its own acquisition by the Tokyo-based conglomerate in 2012. Zoll will acquire all outstanding shares of Itamar for $31 per American depository share (ADS) or $1.03 per ordinary share. The deal represents a more than 50% premium over the price of Itamar’s Nasdaq-listed ADS on Sept. 10. Itamar’s shares spiked 43.41% in premarket trading on news of the acquisition. Read More
Nectero Medical Inc. has secured $19.5 million in a series C financing round, led by Boston Scientific Corp. The company is developing the Endovascular Aortic Stabilization Treatment (EAST) system, a treatment platform that reduces the growth rate of aortic aneurysms. EAST is currently in a multisite phase I safety study for abdominal aortic aneurysm (AAA) patients and the financing will be used to fund further in vivo and clinical development. Read More
There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI. Read More
LONDON – Health data specialist Sensyne Health plc is opening up broader access to its U.S./U.K. patient information system with the launch of a subscription service giving accredited users the ability to interrogate more than 2 million longitudinal electronic health records. At an annual cost of £25,000 (US$34,602) per head, the company will provide “industrial scale” access to anonymized hospital records “to the smallest company or to a single researcher working in academe,” through the new Sensight service, said Paul Drayson, CEO. Read More
A comprehensive nontargeted metabolomics analysis has revealed previously unknown classes of disease-linked metabolites in whole blood samples from dementia patients, which may have significant therapeutic implications for managing the untreatable common cognitive disorder. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Icecure, Miach Orthopaedics, Mimedx, Promis Diagnostics, Tela Bio. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Visby Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: A.Medical, American Academy of Sleep Medicine, Biovica, Dassault, Labcorp, Lantheus, Medial Early Sign, Mindbeacon, Immunovia, JW Bioscience, Radius, Reflexion, Roche Diagnostics, Somalogic, Telemis, Telix. Read More
