Vapotherm said today that it launched its next-gen Precision Flow Hi-VNI system intended to relieve respiratory stress in spontaneously breathing patients. The Exeter, N.H.-based company touted that the next-gen device features improvements to both its software and hardware intended to improve reliability. The Precision Flow Hi-VNI system is designed to deliver maskless noninvasive ventilation to […]
Vapotherm touts automated oxygen controller in preemie study
A recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range. The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared with 49 % […]
Vapotherm closes $64m IPO
Vapotherm said today it closed its initial public offering, raising a total $64.4 million in gross proceeds. The Exeter, N.H.-based company developed the Precision Flow line of devices to provide high-velocity heated, humidified and oxygenated air to treat patients with conditions such as pneumonia, chronic obstructive pulmonary disease, asthma and heart failure. Some 1,200 of […]
Vapotherm prices $56m IPO
Vapotherm yesterday priced an initial public offering, aiming to raise $56 million for its respiratory device. Exeter, N.H.-based Vapotherm developed the Precision Flow line of devices to provide high-velocity heated, humidified and oxygenated air to treat patients with conditions such as pneumonia, chronic obstructive pulmonary disease, asthma and heart failure. Some 1,200 of the devices have […]
Vapotherm registers $58m IPO
Vapotherm last week registered for an initial public offering worth nearly $58 million for the respiratory device it’s developing. Exeter, N.H.-based Vapotherm developed the Precision Flow line of devices to provide high-velocity heated, humidified and oxygenated air to treat patients with conditions such as pneumonia, chronic obstructive pulmonary disease, asthma and heart failure. Some 1,200 of […]
Medtronic’s Assurant stent, Aspire study win FDA approval | Regulatory Roundup
The FDA approved a new Medtronic (NYSE:MDT) stent for peripheral arterial disease and green-lighted a pivotal clinical trial of a so-called “artificial pancreas” for Type I diabetics.
The pair of regulatory wins follow a decision that didn’t go Medtronic’s way, after an FDA panel last week recommended against approval of one of its cardiac ablation devices for a type of atrial fibrillation.
Medtronic lands EU approval for CoreValve | Regulatory Roundup
Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European for its percutaneous aortic valve replacement system, CoreValve.
The device is "the only transcatheter aortic valve available in the world that can treat – without surgery – patients with larger valve openings (up to 29mm)," according to a press release.
CoreValve is the largest transcatheter valve available, but can compress into a small delivery system to be deployed in the same delivery system as smaller CoreValve sizes.
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