NextPhase Medical Devices and Proven Process Medical Devices are merging — another example of ongoing medtech contract manufacturing consolidation. The financial terms of the deal were not disclosed in today’s announcement. Get the full story on our sister site Medical Design & Outsourcing.
Proven Process
M2M Communication Considerations in Medical Device Development
Machine-to-machine communication (M2M) refers to the sharing of information between two devices. It is a key component in the rapidly growing “Internet of Things” (IoT), the increasing connectivity of devices in the home, workspaces, industry, and beyond. M2M communication can be as simple as the unidirectional transfer of data or as complex as multiplexed signals […]
What You Need to Know About the ISO 13485:2016 Update
ISO 13485:2016: An Introduction The international standard ISO 13485 governs the manufacture of medical devices. The first edition was published by the International Organization for Standardization (ISO) in 1996. The ISO currently reviews standards at least every five years to determine whether they need to be updated. The first update to ISO 13485 was released […]
LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement
What is a LVAD? How does it work? A left ventricular assist device (LVAD), also called a ventricular assist system or VAS, is a mechanical pump that is attached to the left ventricle of the heart to augment the function of the heart’s main pumping chamber. The left ventricle pumps blood from the heart to […]
The Case for Real-World Evidence (RWE) in Medical Device Development
Medical Devices are used in the real world every day, so shouldn’t they be tested in the real world? You would think so. But the FDA hasn’t necessarily been of that mindset — until now. Per FDA regulations, testing has to be conducted under supervised clinical trials, which have pre-designed protocols. When most think of […]
GI Dynamics taps Proven Process as EndoBarrier manufacturer
GI Dynamics (ASX:GID) said today it inked a contract manufacturing partnership deal with Proven Process Medical Devices. Through the deal, Proven Process will manufacture Boston-based GI Dynamic’s EndoBarrier device at its Mansfield, Mass.-based facilities. Read the whole story on our sister site, Medical Design & Outsourcing
Proven Process, Innoblative Designs partner for novel ablation device
Proven Process Medical Devices said today it was selected by novel ablation developer Innoblative Designs to act as a partner to develop and manufacture their ablation device. Innoblative, originally incubated at Northwestern University’s Center for Device Development, is developing the device to allow operating physicians to ablate surgical margins post excision. “Innoblative’s impressive early-stage success […]
Proven Process to develop cell implant device for Giner
Proven Process Medical Devices said yesterday it signed on to develop and manufacture a cell implant device for Giner used to administer cell therapies for indications such as liver failure, Parkinson’s disease, parathyroid disease, pancreatectomy and Type 1 diabetes. Giner is developing a miniaturized implantable electrochemical oxygen generator to continuously supply oxygen to islets or cells […]
Proven Process, PathMaker Neurosystems ink deal for neurostim device
Proven Process said today that it’s partnering with PathMaker Neurosystems, a clinical-stage neuromodulation company, to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation. Trans-spinal direct current stimulation is a novel form of non-invasive neurostim, Mansfield, Mass.-based Proven Process said. The spinal stimulation uses a direct current to stimulate […]
Proven Process client Flowonix Medical Inc. achieves FDA PMA Approval of Prometra II infusion device
MANSFIELD, MA – Proven Process Medical Devices, Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today that its client Flowonix Medical Inc. has secured PMA-Supplemental approval from the FDA for its next-generation intrathecal infusion device, the Prometra® II system. Approval of this device, […]
