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INDUSTRY NEWS

The latest industry news, interviews, technologies, and resources.
PCB, BioMed
January 22, 2024

FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler. 

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.
ODT
November 10, 2023

Linkcotek's Journey from Mico-Business to Multi-Million Dollar Global Company

The company’s transformation into a global player is a testament to entrepreneurial spirit, technological innovation, and dedication to customer service.
Lizzy Lawrence
August 22, 2023

FDA greenlights medical device to combat bladder issues

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.
Conn Hastings
August 21, 2023

Magnetic Tentacle Robots for Minimally Invasive Procedures

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.
Conn Hastings
July 12, 2023

MISHA Knee Shock Absorber: Interview with Anton Clifford, CEO of Moximed

Moximed, a medtech company based in California, has developed the MISHA knee system, an implantable shock absorber for use in patients with knee osteoarthritis.
Sean Whooley
July 12, 2023

FDA updates guidance on paclitaxel-coated devices, determines no link to late mortality risk

The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat PAD.
Lizzy Lawrence
June 14, 2023

Federal advisory group rejects proposal to make medical device tracking easier

“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."
Katie Hobbins
June 14, 2023

Peca Labs Bets on ePTFE for Pediatric Cardiovascular Valves

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.
Katie Hobbins
June 14, 2023

Smith+Nephew Nabs 510(k) Clearance for AETOS Shoulder System

The device is indicated for both anatomic and reverse total shoulder arthroplasty.
Katie Adams
June 14, 2023

Cala Health Launches Wearable Device to Treat Hand Tremors

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.
Spencer Chin
June 8, 2023

Making Manufacturing Appealing to Gen Z Article-Making Manufacturing Appealing to Gen Z

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