Delcath Systems (Nasdaq:DCTH) announced today that it closed its previously announced private placement worth $6.2 million. The interventional oncology company issued and sold nearly 1.45 million shares of its common stock at $2.90 per share. In lieu of common stock, it sold 692,042 pre-funded warrants to purchase common stock. Price per warrant totaled $2.89. The […]
Titan Medical wins new surgical robotics patent
Titan Medical (Nasdaq:TMDI) announced today that the U.S. Patent and Trademark office (USPTO) issued a new patent for its surgical robot. The USPTO issued patent No. 11,504,191, titled “Graphical User Interface for a Robotic Surgical System.” It generally covers a graphical user interface (GUI) overlay of a surgical workspace to track instrument movement. According to Titan, […]
Axonics receives Health Canada approval for rechargeable sacral neuromod
Axonics (Nasdaq:AXNX) announced today that Health Canada approved its fourth-generation rechargeable sacral neuromodulation (SNM) system. Irvine, California-based Axonics’ R20 neurostimulator received labeling for a functional life in the body of at least 20 years. It reduces how frequently a patient must recharge their implanted device to once every six to 10 months. The devices charge […]
Tandem Diabetes Care to acquire patch pump maker AMF Medical
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it acquired AMF Medical, maker of the Sigi patch pump for insulin delivery. Switzerland-based AMF Medical currently develops the Sigi patch pump and does not offer it commercially. The system received FDA breakthrough device designation just over one year ago. AMF Medical designed Sigi as an ergonomic, rechargeable […]
VitalConnect wins Frost & Sullivan innovation award for patient monitoring device
Frost & Sullivan today recognized VitalConnect with its 2022 North America New Product innovation award for its biosensor technology. VitalConnect’s biosensor monitors patients and detects multiple health problems. According to a news release, the platform reduced hospital workloads by enabling home monitoring. Patients who prefer to move freely could use the comfortable, state-of-the-art cardiac monitoring […]
Health Canada licenses Medtronic extended-wear infusion set for insulin delivery
Medtronic (NYSE:MDT) Canada announced that Health Canada licensed its Medtronic Extended infusion set for insulin pumps. The Medtronic Extended Infusion Set is the first and only infusion set labeled for a wear time of up to seven days. The infusion set for delivering insulin from a pump to the body typically requires changing every two […]
Dexcom partners with Green Shield, Health Depot on digital diabetes management service
Dexcom (Nasdaq:DXCM) announced today that it partnered with Green Shield and The Health Depot to expand access to the Dexcom G6. The partnership offers Green Shield plan members convenient access to the G6 real-time continuous glucose monitor (rtCGM). It combines this access with virtual diabetes coaching support. Green Shield plan members eligible for G6 coverage […]
FDA clears RF Medical radiofrequency ablation system
RF Medical announced today that the FDA cleared its Mygen M-3004 generator and specialized electrodes, including Myoblate. The Korea-based thermal ablation system manufacturer made both products commercially available in the U.S. According to a news release, the technologies help to modernize the standard of care for minimally invasive practices. “The world’s medical device market is […]
Boston Scientific to acquire majority stake in interventional tech developer Acotec
Boston Scientific (NYSE:BSX) announced that it intends to make a partial offer to acquire a majority stake in Acotec. Marlborough, Massachusetts-based Boston Scientific’s offer could add up to 65% of Acotec’s shares. Its proposed price totals HK$20 per share. That amounts to approximately $523 million for the 65% stake at current exchange rates. Acotec is […]
Smiths Medical issues urgent device correction for some CADD infusion pumps
Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system. The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no […]
European Commission proposes EU MDR deadline delay until 2028
The European Union’s Health Commissioner today proposed pushing back the deadline for its new medical device regulation (MDR) law. Reuters first reported the news yesterday and confirmed it today. Commissioner Stella Kyriakides proposed a delay for the deadline for companies to comply from 2024 to as late as 2028. According to the report, this comes […]