Legacy MEDSearch

JULY 14, 2023

Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation. In addition, AceConnex Pre-Sutured Fascia is manufactured to ensure consistency and minimize variability compared to allografts that are manually sutured pre-operatively.

FDA 52

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MAY 30, 2023

Food and Drug Administration (FDA). It’s been exciting supporting this project from early concept development through transfer-to-manufacture, and we look forward to its commercial success,” said Duncan Smith, managing partner of Sagentia Innovation. THINK Surgical, Inc., About THINK Surgical, Inc.

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OCTOBER 3, 2023

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100).

FDA 52

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AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

FDA 52

FDA Food and Drug Administration Transportation Recruitment 52

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DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. HemoSonics’ manufacturing, R&D, and Headquarters are based out of Durham, NC. The Quantra System’s easy and fast interpretation enables simple, more efficient point-of-care bleeding management.

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APRIL 12, 2023

Additional development efforts of its proprietary technology platform are underway for tissue fixation, intra-operative shaping of patient-specific implant devices, and site-specific delivery of growth factors, anti-infective agents, and local anesthetic drugs.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

Medico Reach

JULY 3, 2022

Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. Meanwhile, you can prepare promotions, train sales personnel, and handle other jobs. Your sales force must be well-versed in the features and functions of the new product. Establish Launch Objectives.

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APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. restor3d, a research-driven medical device company, announced that the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

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JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

FDA 52

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SEPTEMBER 20, 2022

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. It is approved for sale in the United States, European Union, Japan, and Canada. OpSens Inc. ,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

PM360

AUGUST 9, 2022

At this time, Juul can continue sales in the U.S., When asked about driving diversity in clinical trials, 31% of surveyed oncologists felt the best solution is to create a network of clinical trial sites in underserved communities. EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

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OCTOBER 25, 2022

Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

Marketing 52

Marketing FDA Food and Drug Administration Recruitment 52

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OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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MAY 18, 2023

Food and Drug Administration has granted the Connexus DDI “Breakthrough Device Designation”, which offers an expedited review process for transformative medical devices with the potential to treat irreversibly debilitating conditions. In addition to the funding, Paradromics announced that the U.S.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

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AUGUST 10, 2023

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

Food and Drug Administration 52

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Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. surgeries of its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope), as part of the CONCERTO clinical study, a U.S.-based Individual results may vary.

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DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

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OCTOBER 27, 2023

Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers. FDA in April 2023 for use with an implant from a single implant manufacturer. THINK Surgical, Inc., THINK Surgical is committed to an open implant library. THINK Surgical, Inc., is a privately held U.S.-based

Specialization 52

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MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. For more information, please visit www.vivasuremedical.com.

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Medical FDA Food and Drug Administration Recruitment 98

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SEPTEMBER 21, 2023

Food and Drug Administration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. Altus Capital Partners is a private equity firm that controls investments in middle-market manufacturing businesses. For more information, please visit www.choicespine.com.

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JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. The regulatory clearance of the EyeArt v2.2.0

FDA 52

FDA Food and Drug Administration Recruitment Marketing 52

Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

FDA 95

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Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

Medical 98

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