Masimo (NASDAQ: MASI) has made an advancement in consumer health technology with the announcement of US Food and Drug Administration (FDA) clearance for MightySat Medical. This marks a significant milestone as MightySat Medical becomes the first and only FDA-cleared medical fingertip pulse oximeter available Over-The-Counter (OTC) directly to consumers without the need for a prescription. […]
Dexcom, a notable player in real-time continuous glucose monitoring (rtCGM) globally, confirmed today that Health Canada has given its approval for the next-generation Dexcom G7 Continuous Glucose Monitoring System. The product is intended for people aged two and above who have any type of diabetes. Dexcom Canada, however, has mentioned that the device is not […]
Concept Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). Superficial Femoral Arteries (SFA) are blood vessels located in the thigh region that supply blood to the lower extremities. They are commonly […]
Pulse Medical Technology has announced that its fourth-generation μFR system has received breakthrough device designation from the US Food and Drug Administration (FDA) for pan-vascular diagnosis. The Shanghai-based company founded in 2015, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. It is said to have pioneered […]
Boston Scientific, a US medical device maker, has offered to acquire a stake of up to 65% in Chinese medical technology company Acotec Scientific for a sum of around $523 million. Acotec Scientific offers solutions for vascular interventional and other diseases treatment, including drug-coated balloons and percutaneous transluminal angioplasty balloon catheter. With over 20 other […]
Boston Scientific said that the ACURATE neo2 Aortic Valve System delivered a high procedural success rate of 98.4% and low rates of paravalvular leak (PVL) and mortality in a post-market study. The findings are part of the first results from the ACURATE neo2 post market clinical follow-up (PMCF) study that is assessing the performance of […]
Morepen Laboratories Limited said that it has separated its point of care (POC) medical devices business into a newly formed fully-owned subsidiary called Morepen Devices Limited. The Indian pharma company claimed that its medical devices (POC) business has been witnessing exponential growth for the past several years and has secured a top position in the […]
Boston Scientific has agreed to acquire Baylis Medical Company, a Canadian medical devices manufacturer in the field of cardiology, for $1.75 billion. The deal does not include Baylis Medical Technologies, which develops medical devices in the fields of neurosurgery and radiology. Through the acquisition of Baylis Medical Company, Boston Scientific will get access to the […]
Poly Medicure Limited, an Indian medical devices company, has announced the incorporation of a step-down subsidiary called PolyHealth Medical Inc. in the US. PolyHealth Medical Inc. is a fully-owned subsidiary of Poly Medicure B.V., Netherlands, which in turn is 100% owned by Poly Medicure Limited. Based in Dover, Delaware, PolyHealth Medical Inc. will be engaged […]
Boston Scientific has wrapped up the previously announced $1.07 billion acquisition of the global surgical business of Israeli medical solutions provider Lumenis. The US medical device manufacturer had signed the deal in March 2021 with an affiliate of Baring Private Equity Asia (BPEA), which owns Lumenis. The BPEA affiliate will retain ownership of Lumenis’ global […]