BD (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) for a COVID-19, flu and RSV combination diagnostic. The company designed the molecular test to detect SARS-CoV-2, influenza A and B and respiratory syncytial virus (RSV). It’s used on the BD Max molecular diagnostic system. The test uses a single nasal or nasopharyngeal […]
Dexcom to announce U.S. G7 launch in Super Bowl commercial with Nick Jonas
Dexcom (Nasdaq:DXCM) today unveiled its upcoming Super Bowl commercial that announces the U.S. launch of its next-generation Dexcom G7 CGM. The ad, set to run during the second quarter of Super Bowl LVII on Feb. 12, features musician, actor and philanthropist Nick Jonas. Jonas lives with type 1 diabetes and uses Dexcom’s continuous glucose monitors […]
Lantheus acquires Cerveau and its imaging agent for Alzheimer’s
Lantheus (Nasdaq:LNTH) announced that it acquired Cerveau Technologies, a developer of a positron emission tomography imaging agent for detecting Alzheimer’s disease. Cerveau develops the MK-6240 second-generation F 18-labeled PET imaging agent. It targets Tau tangles in Alzheimer’s disease. Bedford, Massachusetts–based Lantheus intends to pay an upfront payment and potential development and commercial milestone payments. It […]
J&J’s Ethicon completes first robot-assisted kidney stone removal with Monarch platform
Ethicon, a Johnson & Johnson MedTech company, today announced the first robotic-assisted removal of kidney stones using the Monarch platform. Auris Health, an Ethicon subsidiary, received FDA clearance for Monarch for endourological procedures in May 2022. The University of California, Irvine’s UCI Health used the Monarch platform for urology to complete the first procedure. According […]
Venus Concept to cut workforce by 18%
Venus Concept (Nasdaq:VERO) announced today that it plans to implement a restructuring plan that includes a large workforce reduction. The medical aesthetic technology developer also intends to change up its executive leadership team amid the restructuring. Venus Concept plans to cut 70 employees, equalling a reduction of approximately 18% of its global workforce as of […]
Sensydia completes enrollment in study for AI-powered cardiac monitoring device
Sensydia announced today that it completed enrollment in its 225-subject development study for its AI-powered Cardiac Performance System (CPS). Los Angeles-based Sensydia designed the AI-based, non-invasive CPS to use heart sound analysis. It may enable earlier detection and improved therapy guidance for heart failure and pulmonary hypertension patients. CPS uses ultra-sensitive biosensors for the rapid, […]
Candela launches radiofrequency microneedle system
Candela announced today that it launched its new Profound Matrix system for radiofrequency-delivered skin treatments. Marlborough, Massachusetts-based Candela designed the Profound Matrix system to correct, maintain and restore skin. The multi-application system utilizes the Sublime, Sublative RF and new Matrix Pro applicators. Sublime and Sublative RF deliver bipolar radiofrequency (RF) treatments that improve the appearance […]
Glooko picks up security certification for diabetes patient management platform
Glooko announced today that it received ISO 27001 certification for its data management and remote patient monitoring platforms. Palo Alto, California-based Glooko develops remote patient monitoring and chronic care management products. These include data management technologies for insulin delivery devices. ISO 27001, an international compliance framework, serves as the international security standard for protecting customer […]
Align Technology enters $250M accelerated stock repurchase agreement
Align Technology (Nasdaq:ALGN) announced today that it entered into a new accelerated stock repurchase agreement with Citibank. Tempe, Arizona-based Align agreed to repurchase $250 million of its common stock. It falls under its $1 billion stock repurchase agreement announced in May 2021. The company’s most recent buyback took place in October 2022 through a $200 […]
Tidepool Loop automated insulin delivery system wins FDA clearance
Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system. Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors. The company announced collaborations in the past that include […]
Know Labs inks partnerships to accelerate progress toward FDA clearance for glucose monitor
Know Labs (NYSE:KNW) announced that it entered into a series of strategic partnerships as it looks to move toward a major regulatory nod. Seattle-based Know Labs develops the Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. This technology integrates into wearable, mobile or bench-top […]