SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device. Known as SomniFit-S in Europe, the Anti-Snore Mouth Guard+ reduces snoring by positioning the jaw gently forward. It allows for increased airflow and eliminates airway obstruction by tissues inside the mouth, requiring no masks, hoses or electronics. Swiss manufacturer Oscimed SA […]
Dental
FDA clears Kallisio’s 3D-printed oral insert for radiation therapy
Kallisio recently announced that the FDA has cleared its 3D-printed Stentra, used to protect head and neck cancer patient’s healthy tissue during radiation therapy. Stentra is fabricated of bio-compatible nylon materials (nylon ISO 10993-1), using 3D SLS printing technology. Baltimore-based Kallisio says Stentra directs radiation to the target tumor area while reducing the harmful impact […]
Dental robotics company Neocis raises $20M
Neocis, maker of surgical technology for robot-assisted dental implants, announced today that it raised $20 million in additional funding. Maimi-based Neocis received investments from Mirae Asset Capital/Mirae Asset Venture Investment. They have an affiliation with the Mirae Asset Financial group and invest in growth-stage healthcare and technology businesses. NVentures, NVIDIA’s venture capital arm, also participated […]
Align Technology acquires 3D printing company Cubicure
Align Technology (Nasdaq:ALGN) announced that it completed the acquisition of 3D printing company Cubicure. Cubicure offers 3D printing solutions for polymer additive manufacturing. It develops, produces and distributes innovative materials, equipment and processes for novel 3D printing solutions. Tempe, Arizona-based Align plans for the acquisition to support and scale its strategic innovation roadmap and strengthen […]
Align Technology wins FDA nod for Invisalign palatal expander system
Align Technology (Nasdaq:ALGN) announced today that the FDA granted 510(k) clearance for its Invisalign palatal expander system. The direct 3D-printed device provides rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw). It enables primary, mixed or permanent dentition during the treatment of growing patients. FDA clearance covers broad patient applicability, including […]
ZimVie to sell spine business, become pure-play dental company
ZimVie announced today that it agreed to sell its spine business to investment firm H.I.G. Capital. Shares of ZIMV skyrocketed more than 50% to $17.05 apiece by the afternoon. MassDevice‘s MedTech 100 Index was up slightly. The sale of the business, valued at $375 million, establishes ZimVie as a pure-play dental company. Westminster, Colorado-based ZimVie […]
NuEyes wins FDA approval for augmented reality surgical visualization tech
NuEyes announced today that the FDA granted approval to its patent-pending NuLoupes augmented reality smart glasses technology. The Newport Beach, California–based company designed its system with state-of-the-art 3D stereoscopic technology. It offers practitioners in dentistry and medicine precision and live 3D visualization. Surgeons and dentists can move from traditional fixed magnification to NuLoupes high-resolution variable […]
Align Technology makes $100M open market stock repurchase
Align Technology (Nasdaq:ALGN) announced today that it plans to repurchase $100 million of its own common stock. Tempe, Arizona-based Align Technology’s open market repurchase falls under its $1 billion stock repurchase program. The company’s board approved the program in January 2023. Align Technology executed a $250 million repurchase in February of this year with Citibank. […]
ZimVie beats The Street in Q3, ups back end of guidance
ZimVie shares ticked up this morning on third-quarter results that topped the consensus forecast. Shares of ZIMV rose 1% at $6.80 apiece just after the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 1.1%. The (LOCATION)-based company posted losses of $5.1 million […]
Intuitive appoints Align Technology exec to its board
Intuitive announced that it appointed Align Technology executive Sreelakshmi Kolli to its board of directors. Kolli currently serves as EVP and chief digital officer at Align, the maker of Invisalign clear aligners and other dental tech. Her appointment to Intuitive’s board of directors went into effect on Oct. 27, 2023. “Sree has deep expertise in applying technology to transform industries, enable business growth and […]
Align Technology announces $250M accelerated share repurchase program
Align Technology (Nasdaq:ALGN) announced today that it entered into an agreement to repurchase $250 million of its common stock. The company also executed a $1 billion stock repurchase agreement announced in May 2021. Align took care of one buyback in October 2022 through a $200 million repurchase with Goldman Sachs. Align’s board officially approved the current […]