Lumithera Inc. will acquire Diopsys Inc. for an undisclosed amount in an all-stock transaction expected to close in the next few months. The deal has been approved by shareholders of both companies. Together, they plan to form a theranostic company that can provide a continuum of care for patients with age-related macular degeneration and other degenerative ocular diseases or injury.
With its agreement to buy Atos Medical Inc., Coloplast A/S is consolidating its position as a global leader in the chronic care market. Founded in Sweden in 1986, Atos Medical is the largest player for laryngectomy devices, holding a market share of more than 80%. It’s a bold move from the Humlebaek, Denmark-based company as it offers to pay $2.5 billion to acquire the Nottingham, U.K-based company from private equity firm Pai Partners.
TORONTO - Medtronic Canada ULC, a subsidiary of Dublin-based Medtronic plc, has launched what it calls the “the first dedicated robotic assisted spine surgery platform in Canada.” The Mazor integrates surgical planning, workflow and execution by combining navigation and robotic technologies.
India is home to just one of several regulatory entities that have overhauled their med-tech regulatory apparatus in recent years, but the Central Drugs Standard Control Organization (CDSCO) has also joined the COVID-19 regulatory delay club as well.
Arthrex Inc., of Naples, Fla., is well known for lobbing a legal hand grenade into the inter partes review (IPR) process for patent disputes, but the company is now drawing ink for a different legal reason. According to the U.S. Department of Justice (DoJ), Arthrex has agreed to pay $16 million to settle allegations that it engaged in kickbacks to a surgeon, payments ostensibly made to pay for assistance with device design, but which the DoJ claims were intended to induce the surgeon’s use and endorsement of Arthrex products.
The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the proposal to provide automatic Medicare coverage of FDA breakthrough devices, but the proposal may not be as dead as it once seemed.
PARIS – The French National Agency for the Safety of Medicinal and Healthcare Products (ANSM), has published its latest annual report on the drugs and medical devices market in France. This body, placed under the supervision of the Ministry of Health, is responsible for monitoring all healthcare products throughout their cycle, for collating and analyzing reports of adverse reactions, and for implementing corrective action across the nation.
Investors have injected $8.4 million into Swedish startup Sigrid Therapeutics AB to speed development of its oral medical device Sipore15. The technology is a tasteless and odorless white powder taken with water to reduce blood sugar levels in people at risk of developing diabetes.
Two studies presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference directly compared Boston Scientific Corp.’s Watchman 2.5 and Watchman Flx to Abbott Laboratories’ Amplatzer Amulet device. Both showed Amulet had less than half as many leaks, but the clinical impact of the lower rate remained unclear.
Catheter-based delivery of replacement valves is established practice for patients with aortic regurgitation, but the mitral valve has only repair devices to address this condition. However, transcatheter mitral valve replacement (TMVR) devices by Dublin-based Medtronic plc., and triscupid valve replacement devices by Edwards Lifesciences Inc. of Irvine, Calif., made some noise at this year’s edition of Transcatheter Cardiovascular Therapeutics (TCT), suggesting that these patients might soon have a wider range of options.