Check-Cap (NSDQ:CHEK) said it finalized a manufacturing line transfer implementation and qualification with the healthcare business at General Electric (NYSE:GE) for its C-Scan system, a preparation-free ingestible scanning capsule-based system designed to prevent colorectal cancer. The C-Scan system is in the midst of a pilot clinical trial at the New York University School of Medicine and […]
EndoStim raises $25m Series D for neurostim GERD device
Five months after spiking its plans for an initial public offering, EndoStim said today that it raised a $25 million Series D round for the neurostimulation device it’s developing to treat gastroesophageal reflux disease. Saint Louis- and Nijmegen, Holland-based EndoStim said Endeavour Vision led the round, joined by existing backer Santé Ventures and new investors Wellington Partners and Gimv. Endostim […]
Rock West Medical Devices raises $1.3m
Rock West Medical Devices said in a regulatory filing that it raised $1.25 million from a single, unnamed investor. San Juan Capistrano, Calif.-based Rock West Medical is a subsidiary of Rock West Solutions, which according to its website provides R&D and product development services for advanced composite structures and applied sensors. The company ultimately hopes to raise $3 million […]
EXCLUSIVE: FDA says ReShape Medical can skip advisory panel for obesity balloon device
ReShape Medical, which is developing a balloon system to combat obesity, notched a significant victory in its path to commercialization, CEO Richard Thompson told MassDevice.com today.
Regulators at the FDA waived a requirement that the San Clemente, Calif.-based company appear before an advisory committee for its premarket approval application, Thompson told us. That removes a significant amount of uncertainty from the arduous PMA process for the ReShape Duo device, he said.
Medtronic wins HDE for Enterra II neurostim device
Groundbreaking Study Demonstrates Dramatic Histopathological Changes With Stretta and Secca (Press Release)
NORWALK, Conn. — A newly published, pathologist-blinded study in a porcine model, examines the histopathology changes after non-ablative radiofrequency (NARF) to smooth muscle as delivered by Stretta therapy for GERD and Secca therapy for fecal incontinence. Radiofrequency therapy is commonly thought of in terms of ablation, where tissue destruction occurs.
FDA approves Avantis Third Eye Panoramic colonoscopy device
Avantis Medical Systems said the FDA approved its Third Eye Panoramic digital imaging device for colonoscopies.
Medigus raises $5.6M, touts clinical results for acid reflux device
Acid reflux: Medigus raises $11M from U.S. and Israeli groups
Verisante, Astoria join forces for upper GI cancer detection
EndoGastric Solutions raises $30M in support of acid reflux device
California-based EndoGastric Solutions touted $30 million raised in a Series G fundraising round in support of its acid reflux treatment device.