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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Jan. 25, 2022

View Archived Issues
Pico 7, Pico 14 and Pico 7Y devices

Smith & Nephew scores new indications for Pico wound therapy systems

Smith & Nephew plc added new indications for use of its Pico 7 and Pico 14 single-use negative pressure wound therapy (sNPWT) systems. The FDA cleared the London-based device maker’s systems for reducing the incidence of both deep and superficial incisional surgical sites and dehiscence. Smith & Nephew’s Pico 7Y system, which treats two wounds simultaneously, was also cleared to aid in the reduction of the incidence of superficial incisional SSIs for high-risk patients in class I wounds, post-operative seroma and dehiscence. Read More
Quell device image

FDA grants Neurometrix second breakthrough device designation

Neurometrix Inc. secured breakthrough device designation from the FDA for its Quell technology for chemotherapy-induced peripheral neuropathy (CIPN) just six months after receiving the designation for fibromyalgia in July 2021. Quell is a wearable, credit card-sized transcutaneous electrical nerve stimulation (TENS) device worn on the upper calf that delivers self-adjusting, high-power nerve stimulation that disrupts pain signals sent to the brain. Read More
EMA icons

New EU mandate strengthens EMA’s emergency preparedness role

The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis. Read More
Clinical trial virtual display

Legal issues still at play in FDA final guidance for patient input in clinical trial design

The FDA’s device center has published two guidances dealing with patient engagement in relation to the conduct of clinical trials, including a final guidance for patient input into clinical trial design. The final guidance is mum, however, as to whether consultations with patient representatives constitutes a violation of the Anti-Kickback Statute (AKS), a predicament the Advanced Medical Technology Association (AdvaMed) said may represent a serious legal hazard for device makers. Read More
Close-up of elderly eye

Microkpro receives NMPA’s first approval of artificial cornea free of biological materials

Beijing Microkpro Medical Instrument Co. Ltd. has received marketing approval for its artificial cornea from China’s NMPA. Miok Keratoprosthesis is the world’s first artificial cornea made of 100% non-biological materials and does not require co-implantation of donor corneas, according to Microkpro Medical. Read More

Appointments and advancements for Jan. 25, 2022

New hires and promotions in the med-tech industry, including: Capitainer, Channel Medsystems, Hyalex, Melzi, Uber Health. Read More

Financings for Jan. 25, 2022

Med-tech firms raising money in public or private financings, including: Spartha Medical. Read More

In the clinic for Jan. 25, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Intersect ENT. Read More

Other news to note for Jan. 25, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, Icad, Iterative Scopes, Janssen, Next Kidney, Stryker, Third Eye, Vocera Communications. Read More

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