Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, 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. ” About Inspira Technologies OXY BHN Ltd. Are you hiring?

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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., Are you hiring?

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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 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 ReddyPort elbow safely delivered 45,000 compliant oral care sessions to patients under FDA Emergency Use Authorization (EUA). Are you hiring?

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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 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Also, we recognize the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. Moximed is based in Fremont, California.

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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. For more information, visit Innoblative.com. Are you hiring?

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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. Otsuka Medical Devices”) announce the U.S.

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Medical Food and Drug Administration FDA 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. We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the U.S.”

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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. ABOUT PROPRIO Proprio is a leading medical technology company creating the new way of seeing in surgery.

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FDA Food and Drug Administration Recruitment Medical 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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FDA Food and Drug Administration Recruitment Medical 52

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 Are you hiring?

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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). This recent FDA clearance of our first device for ophthalmic use advances us toward our ultimate goal of promoting human health and equality.” Click HERE to learn more.

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Pharmaceutical Technology

APRIL 12, 2023

Under its terms, Pharming has paid a $10m milestone payment to Novartis for the first commercial sale of Joenja. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients. Both genes are important for the body’s development and for the functioning of immune cells.

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pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

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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. Press Release by: Cytovale. Are you hiring?

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Evolve Your Success

JANUARY 31, 2023

In this episode, Samuel Adeyinka interviews John Crowder who covers how to sell effectively in medical sales. Tune in now and get medical sales-ready! — Watch the episode here Listen to the podcast here Selling Effectively In Medical Sales With John Crowder We have with us another special guest. I’m wonderful.

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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. InTandem, which is designed to be used independently by a patient in a home setting, received Breakthrough Device Designation from the FDA in 2020.

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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. In the U.S.,

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Legacy MEDSearch

MARCH 15, 2023

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

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Food and Drug Administration FDA Recruitment Physicians 97

Pharmaceutical Technology

MAY 10, 2023

Roche has acquired the worldwide rights to develop and commercialise Chinese biotechnology company Zion Pharma’s lead programme, ZN-A-1041. The company will also be eligible for additional payments of up to $610m after achieving specified development, regulatory and sales-based milestones, and for tiered royalties on sales.

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Legacy MEDSearch

APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx.

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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. “This designation recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability. Paradromics Inc.,

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Medical FDA Food and Drug Administration Recruitment 52

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. Are you hiring?

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World of DTC Marketing

SEPTEMBER 7, 2022

Although COVID-19 has slowed the growth of drug sales, the oncology market’s total growth is driven by the targeted drugs in oncology. This leads to a question; “where does it end?” ” The U.S. oncology therapeutics market has reached $71 billion. ” Why are the costs so high? .”

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Legacy MEDSearch

MARCH 21, 2023

Food and Drug Administration (FDA). We look forward to working with the FDA on acceptance of our LUMISIGHT application for review and submitting the PMA for the Lumicell DVS in the second quarter.” Lumicell, Inc., Submission of the LUMISIGHT NDA is a significant step toward achieving this goal.

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Food and Drug Administration FDA Recruitment Medical 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. See Full Press Release at the Source: Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch ® Ventricular Restoration System.

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Food and Drug Administration FDA Medical Recruitment 52

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. 4 “FDA clearance is a major milestone in our mission to make brain state assessments and follow-up interventions an integral part of standard practice.

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FDA Patients Food and Drug Administration Recruitment 52

Pharmaceutical Technology

MAY 16, 2023

The company is also in line to receive an additional $110m in future milestone payments, depending on the Chikungunya vaccine development and sales performance of the two marketed vaccines. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.

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Pharmaceutical Technology

NOVEMBER 8, 2022

Oyster Point Pharma introduced Tyrvaya, a nasal spray approved by the Food and Drug Administration (FDA) to treat dry eye disease, in November last year. These acquisitions could possibly add a minimum of $1bn in sales of Viatris by 2028. Famy Life Sciences has an ophthalmology portfolio that complements Viatris.

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Pharmaceutical Technology

JULY 1, 2022

Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults. Gavreto (pralsetinib) is approved by the FDA for three indications. The therapy is used to treat adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

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Medicine Food and Drug Administration FDA Prospecting 59

Legacy MEDSearch

JANUARY 12, 2023

Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel Absorbable Surgical Hemostat. “This designation provides for a more collaborative partnership with the FDA which should expedite patient access to LifeGel as a game-changing new solution to surgical bleeding management.”

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Pharmaceutical Technology

MARCH 29, 2023

In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and Drug Administration (FDA). This programme has now proceeded into a Phase I clinical trial.

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Pharmaceutical Technology

FEBRUARY 14, 2023

upfront payment and eligible for royalties on net sales. These include site specific conjugation chemistry that leads to low payload release in plasma, a novel Fc-enabled antibody with an improved pharmacokinetic profile and toxicology data that suggests that there is an ability to achieve higher exposures with CRB-701. “We

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Medico Reach

JULY 3, 2022

Begin Preparation Before FDA Approval. Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. The launch date may be closer than you believe with the FDA’s unpredictable timeframe. Complete product documentation and make it easily accessible.

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Pharmaceutical Technology

AUGUST 3, 2022

on meeting specific near-term regulatory, approval and initial commercial sale milestones. A New Drug Application (NDA) for olutasidenib filed by Forma was accepted by the US Food and Drug Administration (FDA), and a regulatory decision is anticipated on 15 February next year. The company is also eligible for another $17.5m

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