Stimdia Medical announced today that it received FDA breakthrough device designation for its pdSTIM system. Minneapolis-based Stimdia’s pdSTIM system is designed to offer a tool in addressing high-risk patients, including those with COVID-19, by providing a minimally invasive neurostimulation solution to awaken and recondition the diaphragm, according to a news release. The platform facilitates the […]
Respiratory
Sandoz announces in-licensing of Kindeva respiratory inhalation aerosol
Sandoz announced that it is in-licensing the commercial distribution rights to a respiratory inhalation medicine from Kindeva Drug Delivery. Princeton, N.J.–based Sandoz in-licensed the rights to the brand and authorized generic of Proventil HFDA (albuterol sulfate) inhalation aerosol, which is immediately available to patients in the U.S., according to a news release. Get the full […]
Calumeo launches dry-heat N95 reprocessor
Calumeo today announced the U.S. launch of a point-of-care N95 mask reprocessing device. The Morgan Hill-Calif.-based company said its Calumeo Clean countertop device uses dry heat to decontaminate N95 masks for reuse, without the use of toxic chemicals. The process takes just over an hour. The device can process six masks at a time and each […]
PerkinElmer completes Oxford Immunotec acquisition
PerkinElmer (NYSE:PKI) announced today that it completed its previously announced acquisition of Oxford Immunotec. Under the acquisition agreement announced in January, London-based Oxford Immunotec’s shareholders will be entitled to receive $22 for each outstanding ordinary share, with the terms of the acquisition valuing Oxford Immunotec’s entire issued and to-be-issued ordinary share capital at $591 million. Get the […]
Ventec Life Systems taps Philips exec as new CEO
Ventec Life Systems announced that its board of directors appointed Jim Alwan as its president & CEO. Bothell, Wash.-based Ventec said in a news release that Alwan will assume the role effective March 15, 2021, while also joining as a member of Ventec’s board of directors. A veteran of more than 25 years in the […]
FDA recommends limiting use of ventilator splitters for COVID patients
The FDA is urging healthcare providers to use ventilator splitters for COVID-19 patients only when there is no alternative. The agency released a letter to providers asking them to consider non-invasive ventilation such as high-flow nasal oxygen or non-invasive positive pressure ventilation before resorting to a ventilator splitter. If a ventilator splitter is the only option, the […]
Electromed rises on Street-beating Q2
Electromed (NSDQ:ELMD) shares ticked up today on second-quarter results that topped the consensus earnings forecast. The New Prague, Minn.-based airway clearance therapy technology developer posted profits of $1.2 million, or 13¢ per share, on sales of $9.5 million for the three months ended Dec. 31, 2020, for a 1.6% bottom-line gain on sales growth of 11.1%. […]
FDA authorizes marketing of device to boost tongue muscles and reduce sleep apnea
The FDA announced today that it authorized the marketing of a device for reducing snoring and mild obstructive sleep apnea. The prescription-only device is used while awake to improve tongue muscle function, which can help prevent the tongue from collapsing backward and obstructing the airway during sleep. It is the first device of this kind […]
Ford designs clear mask to aid hearing-impaired
Ford Motor Company announced that it is ramping up new initiatives to help protect people from COVID-19, including mask development. Dearborn, Mich.-based Ford designed a patent-pending, clear respirator in the hopes of benefitting those with hearing impairments. It expects the respirator to certify to N95 standards of virus protection. The transparent, low-cost, reusable respirators allow […]
FDA grants EUA for CPAP filter to make devices safer around healthcare workers
Azimuth Sleep Solutions announced today that it received FDA emergency use authorization (EUA) for its PortPatch product. PortPatch, a patent-pending product, is designed to expand air filtration capabilities for patient treatment options and to keep healthcare workers safer in patient care areas in which non-invasive ventilatory treatment devices are in use. Memphis, Tenn.-based Azimuth Sleep […]
FDA clears lightweight Inovytec ventilators
Inovytec has announced that the FDA has granted FDA 510(k) clearance for its Ventway Sparrow ventilators. The 2.2 lb. transport and emergency ventilators had previously won FDA emergency authorization for use during the COVID-19 public health emergency. They are already commercialized in Europe, Canada and Australia and are undergoing registration procedures in other countries, according to […]
