Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc.,

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Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death.

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Legacy MEDSearch

DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge.

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FDA Food and Drug Administration Recruitment Medical 95

Legacy MEDSearch

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.

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Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

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Legacy MEDSearch

AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopaedic companies. “We

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Legacy MEDSearch

DECEMBER 6, 2022

Activ Surgical is on the leading edge when it comes to enhancing surgical vision and significantly reducing unintended medical errors, and I am confident that ActivSight will improve surgical outcomes.”. Activ Surgical received 501(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021.

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Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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Legacy MEDSearch

APRIL 27, 2023

Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). However, conventional RF devices are not optimized to treat lumpectomy cavities and can lead to variable treatment depths and incomplete ablations. Contact us to discuss partnering with Legacy MedSearch on your position.

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Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials. The post KORU Medical Systems, Inc.

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Legacy MEDSearch

JANUARY 12, 2023

Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel Absorbable Surgical Hemostat. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Medcura, Inc., Press Release by: Medcura.

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Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. For updates, follow Cytovale on LinkedIn and Twitter. Press Release by: Cytovale.

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Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Potential benefits include: Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure. ” For more information, visit: www.propriovision.com.

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Legacy MEDSearch

JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). The post FDA Clears ReddyPort® Non-Invasive Ventilation Device appeared first on Legacy MedSearch | Medical Device Recruiters.

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Legacy MEDSearch

SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use.

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Legacy MEDSearch

JULY 21, 2023

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. Christophe Vaessen. STeP participation does not imply product authorization.

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Food and Drug Administration Patients Safety Recruitment 52

Legacy MEDSearch

JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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Legacy MEDSearch

JUNE 13, 2023

CorNeat Vision’s EverPatch , a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). ” The CorNeat EverPatch will be launched initially in leading ophthalmic centers in the U.S. in Q3 2023, expanding nationwide later in the year.

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Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Knee OA develops when the joint’s natural shock absorbers, cartilage and meniscus, no longer cushion the joint from daily activities, leading to chronic pain and activity limitation.

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Legacy MEDSearch

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.

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FDA Patients Food and Drug Administration Recruitment 52

Legacy MEDSearch

SEPTEMBER 12, 2023

Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation. The LimFlow System has not been approved for sale in Canada or Japan.

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Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). More than half of stroke survivors aged 65 and older experience reduced mobility, and stroke has become a leading cause of long-term disability. The burden on patient functioning is also profound.

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Legacy MEDSearch

JANUARY 11, 2023

Micronoma , the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). Early detection of lung cancer can lead to a higher survival rate.

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Legacy MEDSearch

MARCH 16, 2023

This delay often leads to cognitive impairment, worse health outcomes, and increased costs,” said Dr. Frans Leijten, Head of EEG Department, UMC Utrecht, the Netherlands. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

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FDA Food and Drug Administration Patients Recruitment 52

Legacy MEDSearch

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.

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FDA Food and Drug Administration Recruitment Manufacturing 52

Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. Food and Drug Administration. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Ancora Heart , Inc.,

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Food and Drug Administration FDA Medical Recruitment 52

Legacy MEDSearch

APRIL 6, 2023

CardioSTAT has now become the leading wearable cardiac monitoring solution in Canada. It is committed to improving cardiac monitoring and accessibility for both patients and physicians, by offering leading edge solutions to major problems in the field of medical testing. See Full Press Release at the Source: Icentia Receives U.S.

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Legacy MEDSearch

MAY 18, 2023

the leading developer of high data-rate brain-computer interfaces (BCI), today announced a $33 million Series A funding round led by Prime Movers Lab. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Paradromics Inc.,

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Legacy MEDSearch

JUNE 16, 2023

Food and Drug Administration. ” About Centinel Spine, LLC Centinel Spine ® , LLC is a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access. The study includes 431 Subjects at 29 sites throughout the U.S. and with oversight from the U.S.

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Food and Drug Administration Recruitment Safety Medical 52

Legacy MEDSearch

AUGUST 10, 2023

It would be expected that with accuracies similar to invasive alternatives, system-wide use would almost certainly lead to resource savings while simultaneously improving outcomes for patients with heart failure.” Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S.

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Legacy MEDSearch

FEBRUARY 16, 2023

Often, conservative treatment leads to lengthy hospitalizations, high nursing home admittance, and a high one-year mortality rate. Food & Drug Administration (FDA). The post CurvaFix Launches Smaller-diameter CurvaFix® IM Implant appeared first on Legacy MedSearch | Medical Device Recruiters.

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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. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Images seen in “straight-ahead” vision are magnified 2.7x

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Food and Drug Administration Recruitment FDA Patients 52

PM360

AUGUST 9, 2022

At this time, Juul can continue sales in the U.S., Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff. EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS. Drug Approvals.

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Healthcare Healthcare Food and Drug Administration FDA 52

Legacy MEDSearch

SEPTEMBER 16, 2022

the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Tasso, Inc.,

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Legacy MEDSearch

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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Legacy MEDSearch

FEBRUARY 21, 2023

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. The post Lumendi Receives 510(k) Clearance for Two New Devices appeared first on Legacy MedSearch | Medical Device Recruiters.

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Legacy MEDSearch

SEPTEMBER 21, 2023

Food and Drug Administration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. The post ChoiceSpine® Announces Standalone Indication for Blackhawk® Ti 3D Printed Cervical Spacer System appeared first on Legacy MedSearch | Medical Device Recruiters.

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