January 2016

LivaNova PLC received a Warning Letter dated December 29, 2015, from the United States Food and Drug Administration (“FDA”) alleging certain violations of FDA regulations applicable to medical device manufacturers at its Munich, Germany and Arvada, Colorado facilities.

MiMedx Group, Inc., the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced that it has recently posted an updated "Certificate to Foreign Government" on its website that describes all of the MiMedx  sheet form allografts and the Food and Drug Administration FDA's certification that the listed products are HCT/P's.

NeuroMetrix, Inc.  announced that it received a 510(k) clearance (K152954) from the U.S. Food and Drug Administration (FDA) for an upgraded version of Quell, the company's over-the-counter, 100% drug free chronic pain relief wearable. Under this 510(k), the Quell device can be controlled directly via the Quell Relief smartphone app. This provides an unprecedented level of convenience and comfort when using Quell to treat chronic pain.

Takeda Pharmaceutical Company Ltd.  and Enterome Bioscience SA (“Enterome”) announced they have entered into a strategic drug discovery collaboration to research and develop potential new therapeutics directed at microbiome targets thought to play crucial roles in gastrointestinal disorders, including inflammatory bowel diseases (e.g. ulcerative colitis) and motility disorders (e.g. irritable bowel syndrome).