Medtronic plc has received U.S. FDA 510(k) clearance and breakthrough device designation for its Ligapass 2.0 ligament augmentation system in spine surgery. The surgical treatment is designed to reduce the reoperation rate for proximal junctional kyphosis (PJK), a complication of adult spinal deformity surgery which disrupts spinal ligaments. Ligament augmentation provides strength to the upper instrumented vertebra and adjacent segments while also reducing junctional stress at those levels. Read More
Davita Inc., lost a U.S. Supreme Court ruling regarding limits to the private payer coverage for outpatient dialysis services despite, a development that took a double-digit bite out of Davita’s shares. However, shares of competitor Fresenius also took a hit, suggesting that the market sees the decision as a major setback for both companies. Read More
Pfizer Australia Holdings Pty Ltd. has revised its offer to acquire digital health company Resapp Health Ltd. after results from an independent data confirmation study of its COVID-19 algorithm failed to meet Pfizer’s required sensitivity and specificity results. Read More
Humacyte Inc. provided its Human Acellular Vessel (HAV) implants to Ukrainian hospitals on the front-line of the Russian invasion as part of the company’s humanitarian relief initiative. Two patients have received the implants for treatment of vascular trauma injuries. One patient had sustained a severe gunshot wound to the leg and the other was injured by shrapnel. Read More
A tightening of rules for biotech listings on the Shanghai STAR Market may have contributed to a visible cool-down in biotech IPOs, with fewer listings in Chinese stock markets in the first half of 2022. Read More
It’s been a decade since the America Invents Act (AIA) transformed the U.S. patent landscape from a first-to-invent to a first-inventor-to-file system and added new contours with the creation of the Patent Trial and Appeal Board (PTAB) to hear post-grant patent challenges outside of court. While the AIA’s inter partes review process and other post-grant procedures have helped weed out weak patents, they’ve also increased the uncertainty and unpredictability of many patents. Now, 10 years on, Congress is assessing how the PTAB has developed in real life and considering what course corrections may be needed. Read More
The U.S. Department of Justice (DOJ) reported an indictment of a physician in Paducah, Kentucky for causing the filing of false claims to the Medicare program with the help of telehealth. The physician is liable for only $560,000 in penalties, but the announcement again underscores the department’s crackdown on telehealth fraud, regardless of the dollar value of the fraud. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angle, Astrazeneca plc, Biocartis, Biosig, Bio-techne, Dante, Echosens, Electrocore, Fujifilm Irvine, Ir-Med, Novo Nordisk, Novus Biologicals, Neurovation, OSI Systems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3Spine. Read More
