With a bruising battle with its largest investor barely behind it, Masimo Corp.’s preliminary second quarter results came in nearly $100 million below consensus, putting management in an even tougher position now that it has two new investor-aligned board members. Share price plunged from $147.16 to $110 following the after-hours announcement on Monday. By the closing bell on Tuesday, shares had recovered modestly to $117.73. Read More
Organox Ltd. raised £25 million (US$33 million) in a funding round that will allow the company to expand its operations in the U.S. on the back of significantly increasing demand from transplant centers, Oern Stuge, executive chairman, at Organox told BioWorld. The Oxford, U.K.-based company which makes systems to preserve and transport livers for transplant is also preparing for its eventual listing on Nasdaq, he added. Read More
A committee of the U.S. House of Representatives met to review the Medicare coverage procedure for innovative drugs and devices, an event that seemed to gin up support for legislation that would help to streamline those processes. The problem for drug and device makers, however, may be that the Centers for Medicare & Medicaid Services
continues to labor under a flat appropriations picture that is eroding daily thanks to inflation. Read More
Shineco Inc.’s subsidiary Changzhou Biowin Pharma received marketing approval from China’s NMPA for its test device that can complete a diagnosis of acute myocardial infarction in five minutes. The five-minute cardiac test relies on a combination of three major cardiac markers that can detect cardiac troponin I, myoglobin and heart fatty acid binding protein in a single test. Read More
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial. Read More
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Alzpath, Astellas Pharma, Co-Diagnostics, CRI, Curonix, Endologix, Eko Health, Caredx, Mainz Biomed, Namsa, Natera, Stereotaxis, Viewray. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baird Medical, Reddyport. Read More
