Hillrom (NYSE:HRC) announced today that it received FDA emergency use authorization (EUA) for its MetaNeb system to help COVID-19 patients. Chicago-based Hillrom designed MetaNeb to combine lung expansion, secretion clearance and aerosol delivery into a single therapy session available for use with any ventilator. MetaNeb includes a closed-circuit design with a bacterial-viral filter to protect patients […]
Patient Monitoring
Coala Heart Monitor receives EUA to provide remote heart and lung exams
Coala Life announced today that it received FDA emergency use authorization (EUA) for an expanded indication for its Coala Heart Monitor. The expanded indication for the heart monitor enables physicians to remotely monitor heart and lung sounds in real-time, which can be used in COVID-19 respiratory diagnostic exams. Coala, a Swedish company with a location […]
COVID-19 upends medtech’s financial outlook
The uncertain times brought on by the COVID-19 pandemic have affected businesses worldwide, and several sectors of medtech industry are projecting hits to their bottom lines. A number of companies have announced decisions to withdraw financial guidance, cut hours and/or staff, among other major business decisions. Initial impacts of the global pandemic on Wall Street […]
Medtronic launches COVID-19 monitoring system
Medtronic Care Management Services is launching two new software programs for assessing, monitoring and triaging people concerned about COVID-19 and potential symptoms. The MCMS COVID-19 virtual care evaluation and monitoring system — which Medtronic (NYSE:MDT) announced late last week — is now available to U.S. health systems, plans and employers. It follows the company’s launch of […]
DHS warns on Insulet Omnipod
The U.S. Dept. of Homeland Security (DHS) issued a medical advisory to warn of vulnerabilities with the Insulet (NSDQ:PODD) Omnipod insulin management system. According to the advisory, the affected insulin pumps are designed to communicate using a wireless RF with Insulet’s personal diabetes manager device, but the RF communication protocol does not properly implement authentication or […]
RaySearch Labs issues urgent field safety notice for certain RayStations
RaySearch Laboratories issued an urgent field safety notice in Europe to warn on an issue with the dose calculation for the Siemens (NYSE:SI) virtual wedge in several of RaySearch’s RayStation treatment planning systems. The affected RayStation models listed in the safety notice out of Germany included RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), […]
COVID-19 test development surges with pandemic
Companies around the world are racing to develop and distribute tests for COVID-19 to laboratories and to market other products and services they say can help patients and healthcare providers cope with the pandemic. On March 13, the FDA gave Thermo Fisher Scientific (NYSE:TMO) emergency use authorization (EUA) for a diagnostic test that certain U.S. laboratories […]
Nemaura Medical enters non-binding agreements for its SugarBeat platform
Nemaura Medical (NSDQ:NMRD) announced today that it entered into multiple verbal non-binding agreements for its SugarBeat continuous glucose monitor as it seeks to secure regional and global partnerships. The Loughborough, U.K.–based company expects the agreements to lead to discussions over licensing and collaboration, but can’t guarantee that deals will be struck as planned, or at all, […]
Nemaura Medical launches SugarBeat app
Nemaura Medical (NSDQ:NMRD) announced that it launched its SugarBeat app for continuous glucose monitoring on Android devices in the Play Store as it prepares to debut a subscription-based service. The Loughborough, England–based company’s SugarBeat is a non-invasive and flexible CGM designed to pair with BeatDiabetes, the company’s planned health subscription service for people with Type 2 […]
Companion Medical wins FDA nod for InPen diabetes management system
Companion Medical announced that it won FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation in diabetes management. The new bolus calculator is designed to account for the user’s current glucose level and active insulin to remove the guesswork from insulin dosing. Companion Medical touts the system as the first of its […]
Iradimed appoints new VP of regulatory affairs and quality assurance
Iradimed (NSDQ:IRMD) this week said it appointed Steven Kachelmeyer as VP of regulatory affairs and quality assurance, effective March 10. Kachelmeyer will report directly to president and CEO Leslie McDonnell. He replaces Francis Casey who announced his intention to retire, effective June 30. “Under Fran’s leadership, Iradimed gained regulatory approvals in the U.S., Europe and many […]