Biomimetic Innovations Ltd today announced that OsStic® has been granted ‘Breakthrough Device’ designation by the FDA. The proposed indication statement for this novel new technology is: OsStic® Synthetic Injectable Bone Void Filler is a structural, mechanically enhanced bioadhesive for reduction, provisional fixation, or void filling of peri-articular fractures or defects to enhance structural stability where standard fixation alone cannot provide sufficient support for functional mobilization.

The company’s transformation into a global player is a testament to entrepreneurial spirit, technological innovation, and dedication to customer service.

FDA greenlights medical device to combat bladder issues In the latest edition of STAT's Health Tech newsletter: the FDA greenlights device to combat bladder issues and telehealth companies court payers looking for weight loss programs.

Researchers at the University of Leeds in the UK have developed a magnetic tentacle robot that is intended for use in minimally invasive medical procedures, such as the treatment of tumors in the lungs.

Moximed, a medtech company based in California, has developed the MISHA knee system, an implantable shock absorber for use in patients with knee osteoarthritis.

The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat PAD.

“It’s a setback in patient safety and surveillance,” one expert said, "and will leave us with an insufficient regulatory system for identifying unsafe devices."

The company announced the first-in-human implant of its Masa valve, saying the device could be a significant improvement in the treatment of pediatric cardiovascular congenital heart defects.

The device is indicated for both anatomic and reverse total shoulder arthroplasty.

Cala Health recently launched its kIQ system — which it calls the first noninvasive wearable device cleared by the FDA to temporarily relieve tremors in people with essential tremor and Parkinson’s disease.

IME East panel to explore the issues of attracting younger workers to the dynamic, high-tech manufacturing sector.