Selux Diagnostics Inc. received U.S. FDA 510(k) clearance for its next generation phenotyping (NGP) system, a rapid antibiotic susceptibility test (AST) platform that determines a bacteria’s susceptibility to 14 specific antimicrobial agents in less than six hours. Prompt identification of the narrowest effective antimicrobial for an infection is critical to the battle to preserve the efficacy of critical antibiotics and slow the development of ‘superbug’ infections.
Magstim Inc. received U.S. FDA clearance for use of its Horizon 3.0 and E-z Cool Coil to treat adult patients diagnosed with both obsessive compulsive disorder (OCD) and major depressive disorder (MDD). The company’s non-invasive transcranial magnetic stimulation (TMS) therapy offers an option for patients who do not find adequate relief from the often life-disrupting symptoms of OCD with exposure therapy or medication.
Cytovale Inc. received U.S. FDA 510(k) clearance for its Intellisep sepsis test, which can aid in the diagnosis of the often fatal condition within 10 minutes. Cytovale is one of several companies and collaborations that aim to sharply reduce the time to diagnosis and the mortality rate for sepsis by providing quicker, more informative test results and standardizing protocols.
Shockwave Medical Inc. will acquire Neovasc Inc. for just under $108 million, if all terms of the deal are met. Shockwave will pay $27.25 in cash for each of Neovasc’s 2.71 million outstanding shares or approximately $73.78 million at close. Shockwave said the offer corresponds to an enterprise value of $100 million. Neovasc could receive an additional payment of up to $47 million, if the company’s Reducer system for refractory angina obtains U.S. FDA marketing approval within a specified time frame.
Dexcom Inc. appears poised for a very strong year with multiple new products, including the long-awaited G7, having recently received regulatory green lights in the U.S. and Europe. In addition, recommendations to expand coverage of continuous glucose monitors (CGMs) for individuals with type 2 diabetes promise to open the market to millions of new patients. Dexcom CEO Kevin Sayer provided new details and updated guidance at the J.P. Morgan Healthcare Conference in San Francsico earlier this week and the company released preliminary results for the fourth quarter and full year of 2022.
Newly spun out GE Healthcare Technologies Inc. presented preliminary results for the fourth quarter and full year 2022 at the 41st annual J.P. Morgan Healthcare Conference on Tuesday. The update followed the announcement of plans to purchase Imactis SAS, which developed CT-Navigation, a stereotactic needle guidance system. Terms of the Imactis deal were not disclosed.
A panel at the J.P. Morgan Healthcare Conference touched on how multiple remote patient monitoring devices and management can be streamlined via machine learning to identify patients who need follow up, in many cases in their homes, increasing value without increasing the burden on already short-staffed health care organizations. The panelists saw technology as a way around a shortage of providers that could both increase access to care and deliver more targeted acute care while also addressing factors in health disparity to prevent development of disease.
Imperative Care Inc. received U.S. FDA 510(k) clearance for its Zoom Rdl radial access system for treatment of ischemic strokes. The device is designed to enhance radial access for removal of clots in patients with tortuous anatomy and other challenges to the femoral access typically used, providing more options for both patients and physicians.
Baxter International Inc. wasted no time in tackling its New Year’s resolution to trim down the business. On Friday morning, the company revealed details around the divestitures it foreshadowed in its third quarter 2022 earnings call with the announcement that it planned a tax-free spin off its Renal Care and Acute Therapies businesses into an independent, publicly traded company within the next 12 to 18 months.
Zimmer Biomet Holdings Inc. (ZBH) agreed to acquire Embody Inc. for $155 million at closing with an additional $120 million in contingent milestone payments over the next three years. The deal includes Embody’s entire portfolio of collagen-based regenerative solutions for soft tissue injuries. The transaction is expected to close in February.