Medical device regulations continue to grow more complicated. For … [Read More...] about Regulatory Transformation Demands New Business Cases and KPIs
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Enhancing Supplier Quality Management During Constant Change
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Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. These are usually followed by validation […]
Making Advanced Metrology Work for You
Evolving Technologies with Next-Level Capabilities
Over the past 18 months, Hobson & Motzer has significantly elevated its inspection and metrology capabilities. This runs parallel the company’s historical pattern of advancing technology by consistently adding the latest manufacturing equipment and process capabilities. In med device, the cadence of innovation and breakthroughs in device technology requires highly capable, innovative suppliers. Not only […]
Trusted Medical Industry Partners
Trusted Medical Industry Partners At Apple Rubber, we understand the medical industry’s need for precision, dependability, and adherence to the highest of standards. When the success or failure of a life-saving medication, vaccine, medical material, or piece of equipment can depend on the effectiveness of a single sealing device, failure just isn’t an option. How […]
Mergers & Acquisitions.
Report: ICU Medical, GE HealthCare to battle over Medtronic units
Reuters reported today that ICU Medical and GE HealthCare are pursuing two business units Medtronic aims to sell off. The outlet cites sources familiar with the situation, saying the companies are looking at Medtronic’s patient monitoring and respiratory interventions businesses. According to Reuters, Medtronic values these businesses between $8 billion and $9 billion. In October, Medtronic […]
Pear Therapeutics stock sinks as it may look for a sale or merger
Pear Therapeutics (Nasdaq:PEAR) announced today that it engaged in a process to explore strategic alternatives to maximize shareholder value. Shares of PEAR fell more than 30%to 41¢ apeice in midday trading on the back of the news. MassDevice‘s MedTech 100 index, which includes stocks of the world’s largest medical device companies, was up slightly. Boston-based […]
Getinge acquires Ultra Clean Systems for $16M
Swedish medtech company Getinge announced today that it will pay SEK 170 million ($16 million) to acquire Ultra Clean Systems and its ultrasonic cleaning tech. Getinge has already been the exclusive North American distributor of Tampa, Florida–based Ultra Clean Systems’ offerings for nearly a decade. Health providers use ultrasonic cleaning tech in hospitals and surgery […]
HeartBeam acquires patient monitoring assets from Livmor
HeartBeam (Nasdaq:BEAT) announced today that it acquired substantially all assets from Livmor, which develops remote monitoring technology. Livmor, a digital health solutions company, provides a patient-engaging remote monitoring system for critical physiological biomarkers. HeartBeam said in a news release that the acquisition extends its reach in remote monitoring and detection. It now has full ownership […]
Vivasure wins FDA IDE approval, receives €30M from Haemonetics
Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical study of its PerQseal device. Additionally, Galway, Ireland-based Vivasure announced a €30 million ($32.2 million) investment from Haemonetics. It marks part of the company’s Series D financing, for which the initial $23 million tranche closed in May 2022. The […]
Bigfoot Biomedical takes next steps for its holistic diabetes management platform
After executing a significant IP sale, Bigfoot Biomedical looks to double down on its diabetes management platform. Less than two years ago, Bigfoot Biomedical launched its Bigfoot Unity platform in some U.S. states. CEO Jeffrey Brewer last year called it a “transformational attempt” to simplify CGMs and the data they produce. It features a smart insulin pen cap, […]
Surgalign sells Coflex, Cofix product lines for $17M
Surgalign (Nasdaq:SRGA) announced an agreement for Xtant Medical (NYSE:XTNT) to acquire two of its product lines for $17 million. On Feb. 28, the two companies entered into a definitive agreement whereby Xtant acquired the Coflex and Cofix product lines from Surgalign. They subsequently closed on the deal for a total consideration of $17 million. Surgalign […]
